ABI-M201 in Adult Subjects With Mildly-to-Moderately Active Ulcerative Colitis

• Status: Terminated
• Trial end date: 2021-01-20
• Target enrollment: 0
• Participant gender: All

Summary

Phase 1B randomized, double-blind, placebo-controlled, two-cohort clinical trial of ABI-M201 in adult subjects with mildly-to-moderately active Ulcerative Colitis(UC) and ongoing treatment with mesalamine.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assembly Biosciences
• Collaborator: Allergan

Criteria

Inclusion Criteria:

• Established diagnosis of UC for at least 3 months prior to screening, with minimum disease extent of 15 cm from the anal verge

• Mildly to moderately active UC

• Inadequate response to ongoing treatment with oral mesalamine ≥2.4 g/day for ≥4 weeks from screening visit

Exclusion Criteria:

• Possible or confirmed diagnosis of Crohn's Disease or other forms of inflammatory bowel disorders

• Ongoing or failed prior treatment for UC with methotrexate, azathioprine, 6-mercaptopurine, cyclosporine, tofacitinib, mycophenolate mofetil, sirolimus (rapamycin), thalidomide, tacrolimus (FK-506), or biologics (e.g., TNF-alpha-antagonists, anti-integrin therapies, or agents targeting IL-12 or IL-23, etc.)

• Any immunosuppressive condition or treatment with immunosuppressive medications

• History of prior surgical intervention in any region of the gastrointestinal tract (excluding minor surgery)

• Prior diagnosis of any cardiovascular, renal, hepatic, endocrine, infectious, hematological, oncologic, neuro-psychiatric or immune-mediated disorder, which in the opinion of the Principal Investigator might impact the subject's safety or compliance, or the interpretation of results

• Treatment with any other investigational drugs ≤12 weeks prior to baseline visit

• The participant has a condition or is in a situation which, in the Principal Investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study